a study of different doses of megestrol acetate in patients with aids who have anorexia and malnutrition

Conditions: Anorexia; Cachexia; HIV Infections

Summary: to compare the effects of megestrol acetate and placebo on body weight, anorexia, cachexia, calorie intake, and nutritional parameters of patients with a confirmed diagnosis of aids. to characterize dose response in relation to weight gain. to determine whether megestrol acetate relative to placebo improves the perception of well-being among aids patients with cachexia. to evaluate megestrol acetate's effect on immune function via skin test reactivity, t4/t8 ratio, and total lymphocytes.


Eligibility criteria:
inclusion criteria patient must have: * confirmed diagnosis of aids (cdc definition). * documented weight loss or anorexia. * life expectancy = or \> 20 weeks. * the perception that the weight loss is a detriment to their well-being. * ability to provide informed consent, read and write english. prior medication: allowed: * ganciclovir. exclusion criteria co-existing condition: patients with the following are excluded: * dementia or evidence of mental incompetence which would preclude compliance with the protocol. * diarrhea defined as 5 or more watery stools per day for at least 7 days. * active uncontrolled systemic infections at the start of treatment. * (patients may not be entered for at least 2 weeks after acute infection.) clinical or radiologic evidence of ascites or pleural effusions. concurrent medication: excluded: * therapy designed to treat the underlying hiv infection or which may have a major impact on appetite and/or weight gain. * patients who have been started on zidovudine (azt) within eight weeks. (patients may have been previously treated with azt and failed or may currently be receiving azt for at least 8 weeks.) patients with the following are excluded: * obstruction to food intake or impaired digestive/absorptive functions. * contraindications to high-dose megestrol acetate (poorly controlled hypertension or heart failure or deep vein thrombosis). * inability to consent or be available for close follow-up. * active systemic infections at the start of treatment. * patients may not be started on any therapy designed to treat the underlying hiv infection or which may have a major impact on appetite and/or weight gain. * clinical or radiologic evidence of ascites or pleural effusions. * patients may not be started on any therapy designed to treat the underlying hiv infection or which may have a major impact on appetite and/or weight gain. * patients who have been hospitalized or have suffered an exacerbation of their illness associated with weight loss within the past 2 weeks are excluded. * menstruating female patients are excluded. prior medication: excluded: * corticosteroids. * anabolic steroids. * marijuana. * megestrol acetate. * patients who have been started on zidovudine (azt) within 8 weeks. (patients may have been previously treated with azt and failed or may currently be receiving azt for at least 8 weeks.) history of substance abuse and questionable current and future abstinence.

Keywords: t-lymphocytes megestrol dose-response relationship, drug acquired immunodeficiency syndrome anorexia cachexia